Vimpat (lacosamide) provided sustained efficacy and good tolerability for up to 8 years in patients with partial onset seizures

• Long term data from four open label lacosamide extension
trials reported at the 29th International Epilepsy Congress

• New non-interventional study (VITOBA™) aims to
investigate additive or synergistic effects of lacosamide with
single antiepileptic drug (AED) treatment

Brussels (Belgium) and Rome, 31st August 2011, 0700 CET –
Consistent evidence that adjunctive treatment with Vimpat®
(lacosamide) was generally well tolerated and associated with a
sustained reduction in partial onset seizures for up to 8 years,
was presented this week at the 29th International Epilepsy Congress
in Rome, Italy (28th August-1st September)1-4.

“These data showed that the seizure control and
tolerability seen with lacosamide in pivotal phase III clinical
trials were maintained during open label long term studies, and
they provide additional clinical data to neurologists searching for
long term solutions for adult patients with poorly controlled
partial onset seizures,” said Dr Robert F. Leroy,
Neurological Clinic of Texas, Dallas, Texas, USA.

A further study announced at the Congress – VITOBA™
(VIpatT added to One Baseline AED) - is investigating whether
lacosamide has additive or synergistic effects when added to single
agent AED treatment for partial onset seizures in a real life
clinical setting5. Analysis of data from this six month,
prospective, non-interventional study of 500 evaluable patients
with partial onset seizures should provide comparative insights
into the effects of adding lacosamide to a single “sodium
channel” or “non-sodium channel” AED.

Lacosamide was launched in the European Union in September 2008,
as adjunctive therapy for the treatment of partial onset seizures
with or without secondary generalization in patients with epilepsy,
aged 16 years and older. Lacosamide solution for infusion may be
used when oral administration is temporarily not feasible.

In the US, Vimpat® tablets and injection for intravenous use
were launched in May 2009 as an add-on therapy for the treatment of
partial onset seizures in patients with epilepsy who are 17 years
and older. Lacosamide injection is a short-term replacement when
oral administration is not feasible in these patients. Lacosamide
oral solution was launched in June 2010.

The maximum recommended daily dose for Vimpat® in the
European Union and the US is 400 mg/day.

Long term efficacy and safety from open-label extension trials
SP756, SP774 and SP615

SP7561
• 308 patients enrolled to open-label lacosamide for <5.5
years
• Median reduction in 28-day seizure frequency and ≥50%
responder rate during the treatment period from baseline of SP754
phase III trial was 48.5% and 48.2%, respectively
• Of patients exposed to lacosamide ≥2 years, 3.1% remained
seizure-free through ≥2 years
• Primary reasons for discontinuation: lack of efficacy (26%);
AEs (11%)
• Common TEAEs (≥15%): dizziness, headache, contusion,
nausea, convulsion, nasopharyngitis, fall, vomiting, diplopia.
TEAEs that led to discontinuation in ≥1.0% of patients were
dizziness (1.6%) and convulsion (1.0%)

SP7742
• 376 patients enrolled to open-label lacosamide for <5.5
years
• Median reduction in 28-day seizure frequency and ≥50%
responder rate during the treatment period from baseline of SP755
phase III trial was 49.9% and 50%, respectively
• Of patients exposed to lacosamide for ≥1 year, 3.2%
remained seizure-free for ≥1 year
• Common AEs (≥10%) were dizziness (24%), headache (14%),
diplopia (14%), and nasopharyngitis (14%)
• Discontinuations due to AE were 9% with dizziness (1.3%)
leading to discontinuation in >1% of patients

SP6153
• 370 patients enrolled to open-label lacosamide for < 8
years
• Median reduction in 28-day seizure frequency and ≥50%
responder rate during the treatment period from baseline of
previous trials was 50.8% and 51.2%, respectively
• Common TEAEs (≥15%) were dizziness, headache, nausea,
diplopia, fatigue, upper respiratory tract infection,
nasopharyngitis, contusion, and coordination abnormal
• Discontinuations due to TEAEs were 12.7% with dizziness and
convulsion leading to discontinuation in ≥1% of patients

Summary of long term safety open-label extension trial,
SP9264
• 97 patients enrolled to lacosamide for < 5.5 years
• TEAEs (incidence ≥15%) included dizziness (44.3%),
diplopia (17.5%), and vomiting (16.5%) and most were mild/moderate
in intensity. Only one serious AE (SAE) occurred in more than one
patient (convulsion, n=2)
• One patient discontinued due to SAEs (supraventricular
arrhythmia and atrial fibrillation) and continued lacosamide after
treatment of the SAEs. One TEAE led to discontinuation in more than
one patient (dizziness, n=3)
• Median clinical laboratory values remained within normal
range and changes from baseline were not of clinical relevance.
Small increases in mean PR interval and QRS duration were
consistent with the known lacosamide safety profile and did not
vary with lacosamide exposure.

Important safety information about Vimpat® in the EU and
EEA
Vimpat® is indicated as adjunctive therapy in the treatment of
partial-onset seizures with or without secondary generalization in
patients with epilepsy aged 16 years and older. Lacosamide solution
for infusion is an alternative for patients when oral
administration is temporarily not feasible. Contraindications:
Hypersensitivity to the active substance or any of the excipients;
known second- or third-degree atrioventricular (AV) block. Special
warnings and precautions for use: Treatment with lacosamide has
been associated with dizziness which could increase the occurrence
of accidental injury or falls. Therefore, patients should be
advised to exercise caution until they are familiar with the
potential effects of the medicine. Prolongations in PR interval
with lacosamide have been observed in clinical studies. Cases with
second and third degree AV block associated with lacosamide
treatment have been reported in post-marketing experience.
Lacosamide should be used with caution in patients with known
conduction problems or severe cardiac disease such as a history of
myocardial infarction or heart failure. Caution should especially
be exerted when treating elderly patients as they may be at an
increased risk of cardiac disorders or when lacosamide is used in
combination with products known to be associated with PR
prolongation. Second degree or higher AV block has been reported in
post-marketing experience. In the placebo-controlled trials of
lacosamide in epilepsy patients, atrial fibrillation or flutter
were not reported; however both have been reported in open-label
epilepsy trials and in post-marketing experience. Patients should
be made aware of the symptoms of second-degree or higher AV block
(e.g. slow or irregular pulse, feeling of lightheaded and fainting)
and of the symptoms of atrial fibrillation and flutter (e.g.
palpitations, rapid or irregular pulse, shortness of breath).
Patients should be counseled to seek medical advice should any of
these symptoms occur. Suicidal ideation and behavior have been
reported in patients treated with anti-epileptic agents. Therefore
patients should be monitored for signs of suicidal ideation and
behaviors and appropriate treatment should be considered. Patients
(and caregivers of patients) should be advised to seek medical
advice should signs of suicidal ideation or behavior emerge.
Lacosamide syrup contains sodium methylhydroxybenzoate (E219),
which may cause allergic reaction (possibly delayed). Patients with
rare hereditary problems of fructose intolerance should not take
this medicine. The syrup contains aspartame (E951), a source of
phenylalanine, which may be harmful for people with
phenylketonuria. Both the syrup and solution for infusion contain
sodium. To be taken into consideration for patients on a controlled
sodium diet. Effects on ability to drive and use machines:
Lacosamide may have minor to moderate influence on the ability to
drive and use machines. Lacosamide treatment has been associated
with dizziness and blurred vision. Accordingly patients should be
advised not to drive a car or to operate other potentially
hazardous machinery until they are familiar with the effects of
lacosamide on their ability to perform such activities. Laboratory
abnormalities: Abnormalities in liver function tests have been
observed in controlled trials with lacosamide in adult patients
with partial-onset seizures who were taking 1-3 concomitant
antiepileptic drugs. Elevations of ALT to ≥3XULN occurred in
0.7% (7/935) of lacosamide patients and 0% (0/356) of placebo
patients. Multiorgan Hypersensitivity Reactions: Multiorgan
hypersensitivity reactions have been reported in patients treated
with some antiepileptic agents. These reactions are variable in
expression but typically present with fever and rash and can be
associated with involvement of different organ systems. Potential
cases have been reported rarely with lacosamide and if multiorgan
hypersensitivity reaction is suspected, lacosamide should be
discontinued. Undesirable effects: The most common adverse
reactions (≥10 %) are dizziness, headache, diplopia, and nausea.
Other common adverse reactions (≥1%<10 %) are depression,
confusional state, insomnia, balance disorder, coordination
abnormal, memory impairment, cognitive somnolence,
tremor, nystagmus, hypoesthesia, dysarthria, disturbance in
attention, vision blurred, vertigo, tinnitus, vomiting,
constipation, flatulence, dyspepsia, dry mouth,
pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue,
irritability, injection site pain or discomfort (specific to
solution for infusion), irritation (specific to solution for
infusion), fall, and skin laceration. Refer to the European Summary
of Product Characteristics for other adverse reactions and full
prescribing information. Date of revision: 06 May 2011.

Important safety information about Vimpat® in the U.S.
Warnings and Precautions
AEDs increase the risk of suicidal behavior and ideation. Patients
taking Vimpat® should be monitored for the emergence or
worsening of depression, suicidal thoughts or behavior, and/or any
unusual changes in mood or behavior.

Patients should be advised that Vimpat® may cause dizziness,
ataxia, and syncope. Caution is advised for patients with known
cardiac conduction problems, who are taking drugs known to induce
PR interval prolongation, or with severe cardiac disease. In
patients with seizure disorders, Vimpat® should be gradually
withdrawn to minimize the potential of increased seizure frequency.
Multiorgan hypersensitivity reactions have been reported with AEDs.
If this reaction is suspected, treatment with Vimpat® should be
discontinued.

For full prescribing information on Vimpat®, visit
http://www.vimpat.com/prescribing-information.aspx, and for more
information on Vimpat®, visit Vimpat.com or contact UCB at
(800) 477-7877.

Vimpat® is a Schedule V controlled substance.

Vimpat® is a registered trademark under license from Harris
FRC Corporation.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical
company focused on the discovery and development of innovative
medicines and solutions to transform the lives of people living
with severe diseases of the immune system or of the central nervous
system. With more than 8 500 people in about 40 countries, the
company generated revenue of EUR 3.2 billion in 2010. UCB is listed
on Euronext Brussels (symbol: UCB).

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